E-DRUG: New report on the Safety of Medicines in Sub-Saharan Africa
With an increase in access to new essential medicines in Africa, there is a
greater need to monitor and promote safety, quality, and effectiveness of
medicines. The burden of adverse events from poor product quality, adverse drug
reactions, and medication errors pose great challenges to health care systems,
besides the impact on morbidity and mortality. Yet few developing countries
have the structures, systems, or resources in place to conduct
pharmacovigilance activities, and countries often lack unbiased, evidence-based
information to help guide regulatory and patient safety decisions.
"Safety of Medicines in sub-Saharan Africa: Assessment of Pharmacovigilance
Systems and their Performance" which has been developed by the USAID funded and
Management Sciences for Health (MSH) implemented Strengthening Pharmaceutical
Systems (SPS) Program, addresses this gap and provides a comprehensive
description and analysis of pharmacovigilance systems and their performance in
sub-Saharan Africa. The data was compiled in 2011 using more than 400
literature reviews and assessments in 46 sub-Saharan African countries.
This thorough work presents critical findings-achievements made to date and
challenges countries are faced with-and recommendations to enhance medicine
safety systems in developing countries. All stakeholders including regulators,
public health program managers, pharmaceutical industry, donors, health care
workers, and patients can take key messages from this report on their roles and
responsibilities that will lead to actions to improve patient safety and health
This study was made possible through an interagency agreement between the US
Food and Drug Administration (FDA) and the US Agency for International
Development (USAID). The combined support enabled the SPS Program to implement
the study. The opinion expressed in this report does not necessarily reflect
the official position of the FDA, the USAID or the US Government. The contents
are the responsibility of MSH.
Link to the report:
Recent comments about the report:
"Regulatory authorities have responsibility beyond getting the product to the
market. The lip service that is currently paid to post-marketing surveillance
is well documented by this report...."
Margareth Ndomondo-Sigonda, African Medicines Regulator
"Patient safety should be at the center of all we do. This study has
highlighted how far we are from that goal.... But it is not without hope. In
its recommended strategies, the report shows opportunities exist for everyone
to act. What is needed is the will to act now!"
Eva Ombaka, Visiting Lecturer, St. John's University, Tanzania, and formerly
with the Ecumenical Pharmaceutical Network
"The result of the study clearly showed little efforts by public health
programs. Monitoring and ensuring the safe use of medicines are critical to the
success of these programs. Global partners must, as a matter of urgency,
integrate in their planning phase, functional medicine safety systems to
monitor the effects of donated products."
Paul Orhii, Director General, National Agency for Food and Drug Administration
and Control, Nigeria
"Pharmacovigilance is a critical component of health systems and of importance
to all stakeholders, regulators, industry, health workers, and patients-for
whom it may well be a matter of life and death."
Alex Dodoo, Director, WHO Collaborating Centre for Advocacy and Training in
Pharmacovigilance, Accra, Ghana
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